ABSTRACT
In Chapter 2, we saw that GMP auditing was one of sev eral components in a GMP/Quality System. Many firms define this system in policies found in their quality manual. Firms certified under ISO-9000 or medical device m anu facturers regulated by the U.S. FDA are required to have quality manuals. In addition to the policies covering GMP auditing, firms usually have standard operating proce dures (SOPs) that provide more detail on the auditing pro cess. Some firms also have internal auditing handbooks
tha t provide additional background information, forms, and data collection tools to auditors.
